On December 9, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company that works out of Upstate Medical University’s Central New York Biotech Accelerator (CNYBAC), reported that it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet technology (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596803]).

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Previously known as ZetaFuse, ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

Loy credits the CNYBAC with Zetagen’s success. "The Biotech Accelerator has been instrumental in helping Zetagen access the necessary resources needed to continue to grow and enhance our business," Loy said. "Whether it be educational, business or even physical space capacity, the continued support from the program has been invaluable. During these pandemic times, when so many early-stage companies have found it difficult to survive, the SUNY Bioaccelerator has helped us thrive."

Loy continued, "At Zetagen, we have been grateful to have the Biotech Accelerator as a venue to support and grow our innovative therapeutics."

In addition to laboratory space, startups in the CNYBAC can also gain expert assistance through access to SUNY Upstate faculty, and to specialists in areas such as FDA submissions and intellectual property concerns.

Zetagen started in a collaborative, shared wet lab space within the Biotech Accelerator and then expanded into its own, full lab of more than 900 square feet as its technology and funding has progressed.

Kathi Durdon, executive director of the CNYBAC applauded Zetagen for its success. "Zetagen is a perfect example of how the CNYBAC is fertile ground for the biomedical sciences and biotechnology ventures."

The CNYBAC currently has 22 clients.

On December 9, 2021 CANbridge Pharmaceuticals, Inc. ("Canbridge" or the "company," stock code 1228.HK), a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, reported that it was officially listed on the Main Board of the Stock Exchange of Hong Kong Limited (SEHK) (Press release, CANbridge Life Sciences, DEC 9, 2021, View Source [SID1234596752]).

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CANbridge issued 56,251,000 shares globally at a final offer price of HK$12.18 per share, raising approximately HK$604 million in net proceeds (excluding the 8,437,000 share over-allotment option, which is subject to exercise). Morgan Stanley Asia Limited and Jefferies Hong Kong Limited are the Joint Sponsors of the offering.

A total of seven well known cornerstone investors participated in the IPO, including: RA Capital, Hudson Bay Master Fund Ltd, Janus Investors, General Atlantic, WuXi Biologics, Ruihua Capital and Belinda A. Termeer.

CANbridge is a China-based, rare disease-focused biopharmaceutical company, founded in 2012, that is committed to the research, development, and commercialization of biotech therapies.

CANbridge has developed a comprehensive pipeline of 13 drug assets with significant market potential, including three marketed products; four drug candidates at clinical stage; one at IND-enabling stage; two at preclinical stage and another three gene therapy programs at lead identification stage. The company’s products and product candidates target some of the most prevalent rare diseases, as well as rare oncology indications, including but not limited to, glioblastoma multiforme (GBM) and mucopolysaccharidosis type II (MPS II or Hunter syndrome).

CAN008, the Company’s Core Product, is a glycosylated CD95-Fc fusion protein that is being developed for the treatment of GBM. The Company received the approval for a first-line Phase 2 trial in China in patients with GBM in April 2021 and dosed the first patient in China in October 2021. The Company expects to commercialize CAN008 in China as a combination therapy with the standard of care for GBM (radiotherapy plus chemotherapy). CAN106 is a humanized monoclonal antibody targeting complement C5 that is being developed for the treatment of complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria (PNH). The Company obtained IND approval for CAN106 from China’s National Medical Products Association (NMPA) for PNH in July 2021. In addition, CANbridge is also developing the next generation of gene therapy through internal research and collaboration with leading international biotech companies and academic institutions.

"Listing on the Hong Kong stock exchange is a major accomplishment for CANbridge, which we believe will propel our ongoing development of innovative treatments for the global rare disease market as we advance our pipeline and build our world-class gene therapy research facility," said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. "We are grateful to our long-term investors and sponsors as we continue to drive forward in our mission to bring novel medical treatments to underserved patient populations."

On December 9, 2021 K36 Therapeutics, Inc. ("K36"), a privately held biotechnology company developing breakthrough therapies for the unmet medical needs of cancer patients, reported its $30 million Series A financing co-led by F-Prime Capital and Atlas Venture with Eight Roads Ventures (Press release, K36 Therapeutics, DEC 9, 2021, View Source [SID1234596739]). The funds will be used to advance the company’s lead candidate, KTX-1001, through its first clinical proof-of-concept studies. KTX-1001 is a first-in-class, selective inhibitor of the histone methyltransferase (HMT) MMSET, which is overexpressed in up to 20% of multiple myeloma patients due to a t(4;14) translocation. The company plans to submit an IND for KTX-1001 in the first half of 2022.

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"We are developing KTX-1001 to provide a targeted therapy that specifically addresses the underlying cause of cancer for these multiple myeloma patients. KTX-1001 will be the first therapeutic agent to enter the clinic that directly targets overexpression of MMSET," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "I am excited to be leading an experienced team of drug developers and working with our tremendous group of clinical advisors as we advance this program to rapid human POC studies."

K36 also announced that industry veteran, Lori Kunkel, M.D., has joined the company’s board of directors, bringing with her more than two decades of experience in oncology and immunology drug development, commercialization and corporate strategy.

"Direct inhibition of MMSET as a potential treatment for high-risk t(4;14)-positive multiple myeloma has been eagerly pursued for many years, and I am delighted to be working with the team who is first to take this precision medicine to the clinic," said K36 board member Lori Kunkel, M.D.

"K36 has the potential to address a significant unmet medical need in multiple myeloma patients who are t(4;14)-positive and beyond," said Chong Xu, Ph.D., F-Prime Capital Partner and K36 board member. "This investment reflects our confidence in the K36 team and their ability to rapidly advance the development of KTX-1001. We are proud to support the company on its mission to develop therapies for cancer patients on a global scale."

"K36 has assembled a world-class team of drug developers and clinical advisors and is now well funded to progress KTX-1001 through the clinic," said Jason Rhodes, Atlas Venture Partner and K36 board member. "We look forward to working with the K36 team as the company progresses into its next stage of growth."

On December 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on December 9th, 2021, that its Data & Safety Monitoring Committee (DSMC) has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, DEC 9, 2021, View Source [SID1234596725]). All patients have now been recruited into the study. The safety profile of RV001 (onilcamotide) was considered excellent, and the DSMC concluded that the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. RhoVac currently estimates finalising the study and presenting results in the first half of the 2022. The objective of the study is to show that RV001 (onilcamotide) can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted by the DSMC last week, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous DSMC conclusions on BRaVac, as well as with the findings of the phase I/II study, including follow-up studies. And therefore, the study continues without modifications.

RhoVac CEO, Anders Månsson, comments: "RhoVac has handled its study recruitment well in spite of the difficulties circumstances brought about by the covid pandemic. We had no reason to anticipate anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence and metastatic disease. An effective cancer vaccine with this profile could fulfil a huge unmet medical need in prostate cancer as well as in on other common cancers".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-12-2021 08:42 CET.

On December 9, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the presentation of preliminary translational data from patient biopsies demonstrating immune activation in the tumor microenvironment (TME) after treatment with COM701, Compugen’s potentially first-in-class anti-PVRIG antibody, as a monotherapy and in combination with nivolumab at the TIGIT Therapies Digital Summit (Press release, Compugen, DEC 9, 2021, View Source [SID1234596724]).

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"These translational data are exciting as they represent the first demonstration of immune activation in the TME of patients who have been treated with COM701 monotherapy or in combination with nivolumab and add to previous data showing immune activation in peripheral blood taken from treated patients," said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "In addition, we are encouraged by the observed increases in clonal expansion of T cells, immune infiltration and immune activation in an MSS-CRC patient with a confirmed response after COM701 and nivolumab combination therapy given this is an indication that is unlikely to respond to PD-(L)1 blockade. These results are consistent with our earlier findings supporting PVRIG pathway involvement in early differentiation memory T cell priming and activation and provide important evidence of immune modulation at the location critical for efficacy, the tumor site."

Dr. Ophir continued "These data, combined with our earlier findings suggest PVRIG plays a distinct role within the DNAM-1 axis. We look forward to continued investigation of PVRIG blockade in the clinic which we believe has the potential to drive immune responses to address both inflamed and less inflamed tumor types that are typically unresponsive to current checkpoint inhibitors".

Key new findings from the presentation titled, "Harnessing PVRIG & TIGIT Combination in Anti-Cancer Immunity" presented by Dr. Ophir include:

Increased TME immune activation and TCR clonality was observed in a patient with PVRL2+, PD-L1low MSS-CRC with a partial response following treatment of COM701 in combination with nivolumab
COM701 induced immune activation in the TME of a patient with ovarian cancer, showing increased CD8+ T cells and markers of immune activation
COM701 in combination with nivolumab induced markers of activated dendritic cells in the serum of 2 responding patients
The presentation will be available on the publication section of Compugen’s website.